Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004068
Status:
COMPLETED
Last Update Posted:
2011-10-04
First Post:
1999-12-10
Brief Title:
Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Treatment of Newly Diagnosed High-Grade Gliomas in Patients Ages Greater Than or Equal to 3 and Less Than or Equal to 21 Years With a Phase II Irinotecan Window Followed by Radiation Therapy and Temozolomide
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of irinotecan followed by radiation therapy and temozolomide in treating children who have newly diagnosed brain tumor
PURPOSE Phase II trial to study the effectiveness of irinotecan followed by radiation therapy and temozolomide in treating children who have newly diagnosed brain tumor
Detailed Description:
OBJECTIVES
Evaluate the efficacy of adjuvant irinotecan in children with newly diagnosed high grade gliomas brain stem glioma or high risk grade II astrocytomas in terms of complete and partial response rate in patients with postoperative measurable disease and in terms of the rate of freedom from recurrence in patients with no postoperative measurable disease
Determine the 3 year overall and progression free survival rates in this patient population when treated with adjuvant irinotecan followed by radiotherapy and temozolomide
Assess the hematopoietic toxicity of temozolomide following local radiotherapy in this patient population
OUTLINE Patients receive postoperative irinotecan IV over 60 minutes daily for 5 days on weeks 1-2 Treatment repeats every 3 weeks for 2 courses Following completion of irinotecan and if appropriate patients may undergo a second surgical resection
Within 2 weeks following completion of chemotherapy or within 4 weeks of following a second resection patients receive image guided external beam radiotherapy 5 days per week for 6 weeks Patients with residual tumor less than 35 cm in maximal diameter may undergo boost radiosurgery
At 4 weeks following completion of radiotherapy patients receive oral temozolomide for 5 days Treatment repeats every 3 weeks for 6 courses
Patients are followed every 3 months for 2 years then every 4 months for 3 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 5 years
Evaluate the efficacy of adjuvant irinotecan in children with newly diagnosed high grade gliomas brain stem glioma or high risk grade II astrocytomas in terms of complete and partial response rate in patients with postoperative measurable disease and in terms of the rate of freedom from recurrence in patients with no postoperative measurable disease
Determine the 3 year overall and progression free survival rates in this patient population when treated with adjuvant irinotecan followed by radiotherapy and temozolomide
Assess the hematopoietic toxicity of temozolomide following local radiotherapy in this patient population
OUTLINE Patients receive postoperative irinotecan IV over 60 minutes daily for 5 days on weeks 1-2 Treatment repeats every 3 weeks for 2 courses Following completion of irinotecan and if appropriate patients may undergo a second surgical resection
Within 2 weeks following completion of chemotherapy or within 4 weeks of following a second resection patients receive image guided external beam radiotherapy 5 days per week for 6 weeks Patients with residual tumor less than 35 cm in maximal diameter may undergo boost radiosurgery
At 4 weeks following completion of radiotherapy patients receive oral temozolomide for 5 days Treatment repeats every 3 weeks for 6 courses
Patients are followed every 3 months for 2 years then every 4 months for 3 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G99-1577 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA021765 |
| P30CA021765 | NIH | None | None |
| SJCRH SJHG98 | None | None | None |
| SPRI-P-00112 | None | None | None |